DevicePMAs@therightstef:P020026_S017 / 55-60 JSONTXT

Approval for the 2.25 mm cypher stent on raptorrail rx stent delivery system. The device, as modified, will be marketed under the trade name cypher and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length <= 30 mm in native coronary arteries with a reference vessel diameter of >=2.25 to <=3.50 mm.

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PMA_MER 1 (1)